Transcript Packaging And Labeling control

 Prepared
by: Paras Shah
 Guided by: Dhaval Rathod

Packaging:
Packaging is prepared for goods transportation ,distribution ,
storage, retailing and use.
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Level of packaging:
Primary packaging:
The Primary packaging is the first level of containment that is
directly contact with the finished drug product.
This could be
A blister card or pouch for tablets or capsules.
A glass or plastic bottle for tablets, capsules , powder,
or liquids.
A glass or plastic syringe , ampoules or vials for injectable drug
product.
An aluminum or laminate tube for cream and ointment.
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Secondary packaging.
Tertiary packaging .
 Material
a.
b.
c.
d.
examination and usage criteria:
There shall be a written procedure describing in
sufficient in detail of receipt, identification, storage,
handling, sampling ,and testing of labeling and
packaging materials, such written procedure shall be
followed. labeling and packaging material shall be
sampled and tested before use.
Any labeling and packaging materials meeting
appropriate written specification may be approved and
release for use.
Record shall be maintained for each shipment received
of each different labeling and packaging material
indicating receipt, examination and whether accepted
or rejected.
Labels and other labeling material for each different
drug product, strength, dosage form shall be stored
separately with suitable identification.
e. Obsolete and out dated labels , labeling and
other packaging material shall be destroyed.
f. Use of gang printed labeling of different drug
products or different strength of the same
drug product is prohibited unless the labeling
from gang printed sheet is adequately
differentiate by size ,shape or color.
g. If cut labeling used, labeling and packaging
operation shall include special control
procedure
 Labeling
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issuance;
labeling materials issued for a batch shall be carefully
examined for identity and conformation to the labeling
specified in the master or batch production records.
Procedure shall be written describing in sufficient
detail, the control procedure employed for the issuance
of labeling .
procedure shall be used to reconcile the quantities of
labeling issued, used ,return and shall require
evaluation of discrepancies found between the quantity
of drug finished product and the quantity of labeling
issued when such discrepancies are out side narrow
preset limit based on historical operating data.
All excess labeling bearing lot or control numbers
shall be destroyed.
Returned labeling shall be maintained and stored in a
manner to prevent mix up and provide proper
identification.
 Packaging
and labeling operation
 There shall be a written procedures
design to assure that correct labels
labeling and packaging materials are
used for drug product, such written
procedure are ;
 Prevention of mix ups and cross
contamination by physical or spatial
separation from operation on other drug
product
 Filled drug product container that set a
side and held in unlabled condition for
future labling operation
 Identification
of drug product with a lot or
control number that permit the determination
of history of manufacture and control of batch.
 Examination and packaging and labeling
material for suitability and correctness before
packaging operation.
 Inspection of packaging and labeling facilities
immidiately before used assure that all the
drug products have been remove from previous
operation.
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Control of packaging material:
packaging operation should be conducted
in suitable buildings, facilities and
condition.
The facility should provide appropriate
environment protection ,segregation and
containment for the products being
packaged, so as to eliminate the risk of
cross contamination, mix ups or substitution.
There should be a master batch packaging
record for each product to be packaged and
packaging batch specific copies made from
these.
All commercial finished products should
bear a batch number and an expiry date on
both primary container lbles and cartons.
 Handling
material:
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of printed packaging
Printed packaging material should be stored and
transported in closed containers identified by name,
code number and control number.
Printed packaging material should be stored in secure
area.
To minimize the mix- ups, bar coded roll labels should
be used whenever possible and the bar codes should
be read on line just prior to adherence to the primary
container.
Over printing of labels and cartons with batch number
and expiry should preferably be performed on line.
Specimens of all printed component used should be
added to the batch packaging record.
 Excess
overprinted packaging materials should
be destroyed as soon as possible.
 Excess packaging material not overprinted may
be return to stores only if identified by code
number and control number . The return should
be recorded.
 All printed packaging material must be
accounted for at receipt and during usage.
 The
master batch packaging formula:
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It will contain the following data field:
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Drug product name, identification number and strength.
Names ,identification number and quantities of each
packaging component:
Primary container: bottle, closures and liner, foil, laminates
etc.
Label
Carton
Tamper evident feature
Child resistant feature
Shipper, divider ,other protective packaging
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a.
b.
c.
d.
e.
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Complete description of the equipment to be utilized for the
packaging operation.
Characteristics to be monitored during filling and
packaging.
 Sample requirement and frequency.
 For the specific batch being packaged:
 Batch number of the drug product
 Packaging lot or control number assigned
 Quantities of packs expected and action level
value
 Quantities of each packaging component issued.
 Expiry date to be assigned
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 The
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potential for mix up and cross
contamination may be further reduced by
physical segregation :
A physical barrier between adjacent lines.
Adequate space and physical segregation to
assemble bulk product and packaging
component.
adequate space for assembly of finished
packaged stock prior to transfer to the
warehouse.
Dust extraction bulk table hoppers.
Cover over open hoppers . Open empty
container and filled but uncapped container.
Delay start up until all packaging material are
available.
Labeling
 For
control:
new or changed labeling there must
be in place a procedure that clearly
defines:
a.
b.
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Who is to review and approve the copy.
What each function is to check and approve:
Material management
Production
Marketing
Medical
legal and regulatory affair
Technical service and quality control
Editorial
System manager
c. The reviewer and approvers should preferably
be defined by name.
d. The feedback loops that confirms that the
changes has actually been introduced.
e. A unique numbering system that has clearly
distinguishes between labeling for different
product and strength and also between
different version of the same labeling.
Tamper resistant packaging requirement for
OTC drug:
a. It was consider that prescription products are
maintained under the control of the pharmacist
and consequently are less vulnerable to
tempering.
b. Effectiveness criteria were established instead
of some guidance:
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film wrapper
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blister or strip packs
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bubble packs
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heat shrink bands
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foil, paper or plastic pouches
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bottle mouth inner seals
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 Drug
product inspection
 Packaged and labeled product shall be
examined during finishing operation to
provide assurance that containers and
packages in the lot have the correct
label.
 On line inspection
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Critical defect
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Major defect
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Minor defect
Line clearance :
 the procedure have been established to
prevent mix-ups of products, containers,
components and mistakes in documents
 Mix-ups and mistakes can occurs when
procedures and GMP are not followed.
 Particular care should be taken :
 When starting a new operation
 At change of shift
 When additional components are
needed
line opening :
 It is performed to ensure correct product
,component and documentation for
comment cent of the process operation.
 line cleaning:
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It is performed to remove and clean
from the line all products, components
and department manufacturing
document
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 Reconciliation:
 A process to measure
efficiency of use for
raw material or components.
 on completion of the procedure all the
partial box of leaf lets must be counted. And
all the partial box shall be sealed before
return to warehousing.
 Possible cause of unsatisfactory
reconciliation:
• Mixed or rough label
• Error in initial counts of labels or cartons
• Error in final packed count
• Incompletely count samples, rejects and
returns
• Wrong number of labels or bottles
• Lost of labels or cartons or leaflet
 To
assure that the drug product meets
applicable standard of indentity strenth, quality,
and purity at the time of use. It shall bear and
expiration date determine by stability testing
 Expiration date shall be related to any storage
condition stated on labeling.
 If the drug product is to be reconstituted at the
time of dispencing , its labling shall bear
expiration information for both reconstituted
and unreconstituted drug product.
 Homeopathic drug product shall be exempted
from the requirement of the section.